Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Encora, Inmune, Novocure, Serac, Teijin.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Aardvark, Alkermes, Avadel, Cellprothera, Celyad, Centessa, Eradivir, I-sens, Lifescan, Natus, Nxera, Onconetix, Realbotix, Seres, Therab.
Clinical updates for biopharma and med tech, including data readouts and publications: Annovis, Biovica, Brainscope, Bridgebio, Caredx, Immunesensor, Mesoblast, Surge.
Biopharma and med-tech companies raising money in public or private financings, including: Berlin Heals, Biorestorative, Entirety, Nektar, Neupulse, Neurent, Xilio.
Agios Pharmaceuticals Inc. is preparing to present a mixed bag of phase III Rise Up data to the U.S. FDA in hopes of “full approval” for mitapivat in sickle cell disease (SCD), which would make it its third indication in rare hematology.
A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors. The Paedneo-Vax trial, funded by Canada’s Providence Therapeutics Holdings Inc., in combination with the Australian Government and philanthropic donors, is the first multisite pediatric study to evaluate individualized mRNA vaccines designed specifically for each child's cancer.
Venture capital firms and research institutions have launched the European Life Science Coalition in a bid to strengthen Europe’s VC ecosystem by mobilizing more private and public investment.
Calla Lily Clinical Care Ltd.’s strategic collaboration with Merck KGaA to support the development of Callavid, its intravaginal drug delivery platform, is a “huge validation” of the work the company is doing, Lara Zibners, co-founder and chairman of Calla Lily, told BioWorld.